Back to results

Role of GLP-1 in Hyperinsulinemic Hypoglycemia Post-bariatric Surgery

Primary Purpose

Hypoglycemia

Status

Unknown status

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Exendin (9-39)

Placebo

About this trial

This is an interventional treatment trial for Hypoglycemia focused on measuring Hyperinsulinemic, post-bariatric surgery

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Men and women ages 18-65
BMI 25-40 with a clinical diagnosis of severe symptomatic hypoglycemia after bariatric surgery

Exclusion Criteria:

Acute medical illness, such as acute bacterial or viral syndrome, febrile illness, acute abdominal symptoms, orthopedic injury within one week
History of cardiac failure, renal insufficiency (estimated Crcl<30cc/min), hepatic insufficiency, chronic obstructive pulmonary disease, anemia (Hct<30%), or uncontrolled hypertension (SBP>160 or DBP>100)
Pregnancy
Use of medications that affect glucose metabolism
Fasting glucose >150 or HbA1c>7.5 on Metformin
Women of childbearing potential (will have a pregnancy test, in addition use of abstinence for at least one month prior to study or use two types of contraceptives, hormonal implant or Depo Provera)
Active, uncontrolled psychiatric disease
Participating in other studies or have received investigational medications within the past month or 5 half-lives of the drug, whichever is longer.

Sites / Locations

Stanford University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Exendin(9-39)

Placebo

Arm Description

IV infusion of Exendin (9-39).

IV infusion of normal saline

Outcomes

Primary Outcome Measures

Plasma glucose area under the curve

Secondary Outcome Measures

Plasma insulin area under the curve

Full Information

NCT ID

NCT02550145

First Posted

June 5, 2015

Last Updated

July 1, 2016

Sponsor

Tracey McLaughlin

1. Study Identification

Unique Protocol Identification Number

NCT02550145

Brief Title

Role of GLP-1 in Hyperinsulinemic Hypoglycemia Post-bariatric Surgery

Official Title

The Role of GLP-1 in Mediating Glucose Reductions After Bariatric Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Unknown status

Study Start Date

February 2014 (undefined)

Primary Completion Date

December 2016 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Tracey McLaughlin

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to evaluate the role of GLP-1 in causing extreme postprandial glucose reductions after bariatric surgery in a subset of patients who have severe symptomatic hypoglycemia.

Detailed Description

The physiologic mechanisms mediating the glucose-lowering effect of Roux-en-Y Gastric Bypass (RYGB) or post-Vertical Sleeve Gastrectomy (VSG) are unknown. The reduction in glucose excursions prior to weight loss has lead to postulates that the incretin hormone, GLP-1, may play an important role. The purpose of this study is to evaluate the role of GLP-1 in causing extreme postprandial glucose reductions in a subset of post-bariatric patients through the pharmacologic blockade of the GLP-1 receptor in post-RYGB or post-VSG patients with severe symptomatic hypoglycemia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypoglycemia

Keywords

Hyperinsulinemic, post-bariatric surgery

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Exendin(9-39)

Arm Type

Experimental

Arm Description

IV infusion of Exendin (9-39).

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

IV infusion of normal saline

Intervention Type

Drug

Intervention Name(s)

Exendin (9-39)

Intervention Description

IV infusion of Exendin (9-39) during standardized oral glucose tolerance test (OGTT).

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

IV infusion of Placebo (normal saline) during standardized oral glucose tolerance test (OGTT)

Primary Outcome Measure Information:

Title

Plasma glucose area under the curve

Time Frame

0 to 180 minutes

Secondary Outcome Measure Information:

Title

Plasma insulin area under the curve

Time Frame

0 to 180 minutes

Other Pre-specified Outcome Measures:

Title

Hypoglycemia symptom score

Time Frame

0-180 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Men and women ages 18-65 BMI 25-40 with a clinical diagnosis of severe symptomatic hypoglycemia after bariatric surgery Exclusion Criteria: Acute medical illness, such as acute bacterial or viral syndrome, febrile illness, acute abdominal symptoms, orthopedic injury within one week History of cardiac failure, renal insufficiency (estimated Crcl<30cc/min), hepatic insufficiency, chronic obstructive pulmonary disease, anemia (Hct<30%), or uncontrolled hypertension (SBP>160 or DBP>100) Pregnancy Use of medications that affect glucose metabolism Fasting glucose >150 or HbA1c>7.5 on Metformin Women of childbearing potential (will have a pregnancy test, in addition use of abstinence for at least one month prior to study or use two types of contraceptives, hormonal implant or Depo Provera) Active, uncontrolled psychiatric disease Participating in other studies or have received investigational medications within the past month or 5 half-lives of the drug, whichever is longer.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Colleen Craig, M.D.

Phone

650-736-2056

cmcraig@stanford.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Tracey McLaughlin, M.D.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Colleen Craig, M.D.

Organizational Affiliation

Stanford University

Official's Role

Study Director

Facility Information:

Facility Name

Stanford University School of Medicine

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Colleen Craig, M.D.

Phone

650-350-2153

cmcraig@stanford.edu

12. IPD Sharing Statement

Citations:

PubMed Identifier

27975209

Citation

Craig CM, Liu LF, Deacon CF, Holst JJ, McLaughlin TL. Critical role for GLP-1 in symptomatic post-bariatric hypoglycaemia. Diabetologia. 2017 Mar;60(3):531-540. doi: 10.1007/s00125-016-4179-x. Epub 2016 Dec 14.

Results Reference

derived

Learn more about this trial

Role of GLP-1 in Hyperinsulinemic Hypoglycemia Post-bariatric Surgery

We'll reach out to this number within 24 hrs